Clinical Research Technician Underfill to Clinical Research Assistant

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How to Apply

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Job Summary

Provide all aspects of clinical research coordination.

Clinical Research Technician: This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.

Clinical Research Assistant: This is the entry level position on the Michigan Medicine CRC Career Ladder This position provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.

Responsibilities*

Knowledge of all 8 competency domains is expected:

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork

Duties and Responsibilities

• Candidate will work directly with multiple radiology research faculty to manage all aspects of assigned clinical trials including but not limited to:
• IRB submissions, enrolling, and consenting research subjects. Completing all aspects of assigned trials, CRF submission, query resolution, IRB reporting including AE and/or ORIO. Develop processes and tools to capture data in accordance with ALCOA -C principles.
• Study binder creation and maintenance.
• Sponsor communications, sponsor related activities such as SIV scheduling, monitoring scheduling, and set up.
• Working with internal auditors such as MICHR, Office of Research Compliance, and departmental audits.
• Self-audit assigned trials and assist with auditing other radiology studies.
• Cross coverage on additional trials.

Required Qualifications*

Clinical Research Technician:

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary.

• Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)

or

An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.

or

Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.

Clinical Research Assistant:

• High school diploma or GED is necessary.

Desired Qualifications*

Clinical Research Technician:

• Bachelor's degree is desired.
• Proficient in research protocol submissions.
• Some experience with databases such as RedCap and Excel is preferred.
• Excellent verbal and written communications.
• Candidate must have the ability to communicate concise and accurate information, both verbally and written.
• An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.
• Proven excellent customer service.
• Ability to foresee the needs of faculty and staff they support and respond accordingly.
• Critical thinking skills.
• Ability to quickly understand detailed protocols and develop CRFs, and databases accordingly.

Clinical Research Assistant:

• Associate Degree in Health Science or an equivalent combination of related education and experience is desirable
• An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Work Schedule

40 hours per week; Typical daytime hours from 9am-5pm, but shift hours may flex depending on current research projects

Work Locations

University Hospital, VV (Victor Vaughn Building), Medical Science I

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Additional Information

Supervision Received:

This position receives direct supervision and reports directly to CRC-Project Manager

Supervision Exercised:

None.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled any time after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.